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Data on Two of Rosetta Genomics' Launched Diagnostic Assays to Be Presented at ASCO 2012


Published on 2012-05-31 05:08:05 - Market Wire
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May 31, 2012 08:00 ET

Data on Two of Rosetta Genomics' Launched Diagnostic Assays to Be Presented at ASCO 2012

Posters Demonstrate the Clinical Utility of miRview Assays in Identifying and Classifying Cancers

PHILADELPHIA, PA and REHOVOT, ISRAEL--(Marketwire - May 31, 2012) - Rosetta Genomics (NASDAQ: [ ROSG ]), a leading developer and provider of microRNA-based molecular diagnostic assays, today announced that data from studies demonstrating the clinical utility of two of the Company's miRview® products to identify and classify tumors will be presented at the American Society of Clinical Oncology (ASCO) 2012 Annual Meeting taking place at the McCormick Place Convention Center in Chicago from June 1-5, 2012.

A study highlighting the clinical utility of the Company's miRview® mets² assay for the identification of the tissue of origin in Cancer of Unknown Primary (CUP) patients in a poster entitled "Accuracy of microRNA-based classification of metastases of unknown primary" will be presented at:

Session: Tumor Biology
Type: General Poster Session
Date/Time: Monday, June 4, from 1:15 p.m. to 5:15 p.m.
Location: McCormick Place Hall A, Poster Board #10575
Presenter: George Pentheroudakis, MD, Ioannina University Hospital, Ioannina, Greece

A study demonstrating the ability of miRview® lung to sub-classify lung cancer in a poster entitled "A microRNA-based diagnostic assay for classification of lung tumors on pathological and cytological specimens" will be presented at:

Session: Tumor Biology
Type: Poster Discussion Session
Date/Time: Tuesday, June 5, from 8:00 a.m. to 12:00 p.m.
Location: McCormick Place S100a, Poster Board #10528, Discussion from 11:30 a.m. - 12:00 p.m.
Presenter: Mats Sanden, MD, FCAP, Medical and Laboratory Director, Rosetta Genomics

"We are especially pleased that this growing body of compelling data in support of the clinical utility of our miRview® diagnostic assays is being presented at the prestigious ASCO conference. This is particularly fortuitous timing as we recently received notification that our miRview® mets² assay is to be covered for all Medicare beneficiaries from Novitas Solutions Inc. ("Novitas"), the designated Medicare Administrative Contractor for this assay. Novitas' decision to cover miRview® mets² reflects the clinical importance of determining the tumor origin in hard-to-diagnose metastatic cancers and CUP, a distinction we believe is appreciated by the world's leading oncologists who gather at ASCO," commented Kenneth A. Berlin, President and Chief Executive Officer of Rosetta Genomics.

"The ongoing development and commercialization of site-specific oncology treatments has driven the need for more accurate identification and classification of tumor types. Our miRview® lung assay differentiates primary lung tumors into the four major types and miRview® mets2 accurately identifies the primary tumor type in primary and metastatic cancer including CUP. These are important distinctions that can help guide oncologists in determining optimal treatments. This, along with recently announced Medicare coverage, should enhance our commercial efforts by providing our sales team with the clinical support needed to accelerate the adoption of our miRview diagnostics in oncology," he added.

About miRview®Products
miRview® are a series of microRNA-based diagnostic products offered by Rosetta Genomics. miRview® mets and miRview® mets² accurately identify the primary tumor type in primary and metastatic cancer including Cancer of Unknown Primary (CUP). miRview® squamous accurately identifies the squamous subtype of non-small cell lung cancer, which carries an increased risk of severe or fatal internal bleeding and poor response to treatment for certain therapies. miRview® meso diagnoses mesothelioma, a cancer connected to asbestos exposure. miRview® lung accurately identifies the four main subtypes of lung cancer using small amounts of tumor cells. miRview® kidney accurately classifies the four most common kidney tumors: Clear Cell Renal Cell Carcinoma (RCC), Papillary RCC, Chromophobe RCC and Oncocytoma. miRview® tests are designed to provide objective diagnostic data; it is the treating physician's responsibility to diagnose and administer the appropriate treatment. In the U.S. alone, Rosetta Genomics estimates that 200,000 patients a year may benefit from the miRview® mets and miRview® mets² test, 60,000 from miRview® squamous, 60,000 from miRview® meso, 54,000 from miRview® kidney and more than 1 million patients worldwide from miRview® lung. The Company's tests are offered directly by Rosetta Genomics in the U.S., and through distributors around the world. For more information, please visit [ www.mirviewdx.com ]. Parties interested in ordering the test can contact Rosetta Genomics at (215) 382-9000 ext. 309.

About Rosetta Genomics
Rosetta Genomics develops and commercializes a full range of microRNA-based molecular diagnostics. Founded in 2000, the Company's integrative research platform combining bioinformatics and state-of-the-art laboratory processes has led to the discovery of hundreds of biologically validated novel human microRNAs. Building on its strong patent position and proprietary platform technologies, Rosetta Genomics is working on the application of these technologies in the development and commercialization of a full range of microRNA-based diagnostic tools. The Company's miRview® product line is commercially available through its Philadelphia-based CAP-accredited, CLIA-certified lab. To learn more, please visit [ www.rosettagenomics.com ].

Forward-Looking Statements
Various statements in this release concerning Rosetta's future expectations, plans and prospects, including without limitation, statements relating to the commercial adoption of miRview® mets², or any of Rosetta Genomics assays, in the marketplace, constitute forward-looking statements for the purposes of the safe harbor provisions under The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by these forward-looking statements as a result of various important factors, including risks related to: Rosetta's approach to discover microRNA technology and to work on the application of this technology in the development of novel diagnostics and therapeutic tools, which may never lead to commercially accepted products or services; Rosetta's ability to obtain, maintain and protect its intellectual property; Rosetta's ability to enforce its patents against infringers and to defend its patent portfolio against challenges from third parties; Rosetta's need and ability to obtain additional funding to support its business activities; Rosetta's dependence on third parties for development, manufacture, marketing, sales, and distribution of products; Rosetta's ability to successfully develop its products and services; Rosetta's ability to obtain regulatory clearances or approvals that may be required for its products and services; the ability to obtain coverage and adequate payment from health insurers for the products and services comprising Rosetta's technology; the ability to obtain a formal agreement for Medicare coverage and to maintain an equitable reimbursement valuation; competition from others using technology similar to Rosetta's and others developing products for similar uses; Rosetta's dependence on collaborators; and Rosetta's short operating history; as well as those risks more fully discussed in the "Risk Factors" section of Rosetta's Annual Report on Form 20-F for the year ended December 31, 2011 as filed with the Securities and Exchange Commission. In addition, any forward-looking statements represent Rosetta's views only as of the date of this release and should not be relied upon as representing its views as of any subsequent date. Rosetta does not assume any obligation to update any forward-looking statements unless required by law.